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The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative facial fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence.
Effective pain management is critical to successful postoperative care and is known to decrease patient morbidity, incurred patient and hospital costs, and length of hospital stay. Pain and nausea after surgery for traumatic facial fractures can limit patients' early morbidity, oral intake, and ability to communicate.
The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative mandibular or midface fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence. The primary outcome measure is the amount of opioid that patients receive in PACU in morphine milligram equivalent (MMEs).
The purpose of the study is to define whether a perioperative bupivacaine nerve block results in a decrease in the amounts of opioids and antiemetics that patients receive in PACU after CMF trauma surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine injection | Experimental | The surgeon will be provided with a 10 mL syringe, and he/she will be blinded to the contents of the syringe. The appropriate landmarks will be identified, and a 21, 25, or 27- gauge needle will be used to perform the nerve block with 0.25% bupivacaine. |
|
| Saline injection | Placebo Comparator | The placebo sham injection will be performed in an identical fashion as the nerve block with the exception of using 10 mL of 0.9% saline injection instead of bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine/Epinephrine | Drug | injection |
| |
| Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of a perioperative bupivacaine nerve block on PACU opioid use as assessed by the amount of opioids received in morphine milligram equivalents (MMEs). | To evaluate the impact of a perioperative bupivacaine nerve block on PACU opioid use in patients undergoing operative fixation of facial fractures compared to placebo nerve block assessment of the amount of opioids that patients receive in PACU in morphine milligram equivalents (MMEs) will be calculated. | day 1 or the day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of a perioperative bupivacaine nerve block on antiemetic use as assessed by the numbers who receive opioids and antiemetics, amount of antiemetics, pain score, frequency of emesis, and time until discharge. | To evaluate the impact of a perioperative bupivacaine nerve block on PACU antiemetic use in patients undergoing operative fixation of facial fractures compared to placebo nerve block. Additional variables that will be collected perioperatively include the medications used for induction/maintenance of anesthesia as well as intraoperative analgesia (I.e. fentanyl, hydromorphone, morphine, acetaminophen, ketorolac, etc.), operative time, estimated blood loss, and intraoperative complications. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amrita Hari-Raj, MD | Contact | 314-518-6410 | amrita.hari-raj@wustl.edu | |
| Sara Kukuljan | Contact | 314-362-7563 | kukuljas@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amrita Hari_Raj, MD | Washington University School of Medicine | Principal Investigator |
| Jay Piccirillo, MD | Washington University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34978529 | Background | Hedegaard H, Minino AM, Spencer MR, Warner M. Drug Overdose Deaths in the United States, 1999-2020. NCHS Data Brief. 2021 Dec;(426):1-8. | |
| 31609864 | Background | Abraham AJ, Rieckmann T, Gu Y, Lind BK. Inappropriate Opioid Prescribing in Oregon's Coordinated Care Organizations. J Addict Med. 2020 Jul/Aug;14(4):293-299. doi: 10.1097/ADM.0000000000000569. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Double-blinded, placebo-controlled randomized clinical trial
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All study team members and the participants will be blinded to the assignment of participants in the study groups. Only the pharmacist will prepare the study syringes and the unblinded statistician will have access to the study group assignments.
| Drug |
injection |
|
| within 1 month post surgery |
| Background | BJC Healthcare. Level I Trauma Center. Barnes-Jewish Hospital. https://www.barnesjewish.org/Medical-Services/Trauma-Acute-CareSurgery/Level-I-Trauma-Center |
| 32097326 | Background | Lapidus JB, Santosa KB, Skolnick GB, Som A, Cho GJ, Waljee JF, AuBuchon JD, Patel KB. Opioid Prescribing and Use Patterns in Postsurgical Facial Trauma Patients. Plast Reconstr Surg. 2020 Mar;145(3):780-789. doi: 10.1097/PRS.0000000000006588. |
| 30119988 | Background | Perloff MD, Chung JS. Urgent care peripheral nerve blocks for refractory trigeminal neuralgia. Am J Emerg Med. 2018 Nov;36(11):2058-2060. doi: 10.1016/j.ajem.2018.08.019. Epub 2018 Aug 8. |
| 33617355 | Background | Staity G, Saadi RA, Pool C, Lighthall JG. The Safety Profile of Liposomal Bupivacaine Use in Septorhinoplasty. Facial Plast Surg Aesthet Med. 2022 May-Jun;24(3):202-206. doi: 10.1089/fpsam.2020.0544. Epub 2021 Feb 22. |
| 36106969 | Background | Schumacher JK, Cristel RT, Talugula S, Shah AR. The Use of Adjunctive Perioperative Nerve Blocks in Rhinoplasty in the Immediate Postoperative Period. Facial Plast Surg Aesthet Med. 2023 Jul-Aug;25(4):361-362. doi: 10.1089/fpsam.2022.0125. Epub 2022 Sep 14. No abstract available. |
| Background | The University of Iowa Otolaryngology Protocols. https://medicine.uiowa.edu/iowaprotocols/maximum-recommended-doses-andduration-local-anesthetics |
| 17695343 | Background | Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |